Urinary Bladder NeoplasmsPhase 3NCT07804056
A Study to Investigate the Efficacy and Safety of Alpha1H as a Neoadjuvant Therapy in Participants With Low- to Intermediate-Risk/Low-Grade Papillary Non-Muscle Invasive Bladder Cancer
A Phase 3 study testing Alpha1H, Transurethral Resection of Bladder Tumor (TURBT) and Intravesical Chemotherapy in people with Urinary Bladder Neoplasms and Non-muscle Invasive Bladder Cancer (NMIBC), run by Hamlet Pharma AB at 1 site in Czechia.
Trial summary
The goal of this clinical trial is to learn if the drug Alpha1H works to treat low-to-intermediate risk non-muscle-invasive bladder cancer in adults. It will also learn about the safety of drug Alpha1H. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder Neoplasms, Non-muscle Invasive Bladder Cancer (NMIBC)
- What is being tested?
- Alpha1H, Transurethral Resection of Bladder Tumor (TURBT) and Intravesical Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteCzechia
- Study dates
- 17 Sep 2026to Jul 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent.
- Low- or intermediate-risk non-muscle-invasive bladder cancer (NMIBC) meeting one of the following definitions:
- Low-risk NMIBC: Primary, solitary, Ta, low-grade, 0.5 cm to 3 cm.
- Intermediate-risk NMIBC (low-to-intermediate risk subgroup per IBCG classification):
- Primary multifocal (<10 lesions), Ta, low-grade, 0.5 cm to 3 cm;
- Recurrent solitary, Ta, low-grade, 0.5 cm to 3 cm; or
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- Recurrent multifocal (<10 lesions), Ta, low-grade, >1 year after previous recurrence.
- Men and women aged 18 years or older.
- Negative pregnancy test at screening for women of childbearing potential.
- Women of childbearing potential must agree to use highly effective contraception methods throughout study participation; men of childbearing potential must refrain from donating sperm during the study.
- Ability to retain bladder contents for 2 hours.
Who cannot join
- Patient with non-papillary tumor appearance at the time of initial cystoscopy.
- Previous history of T1 or high-grade disease in recurrent tumors.
- Patients with T1 or high-grade non-muscle invasive papillary bladder cancer (NMIBC).
- Previous intravesical BCG immunotherapy.
- Patients with any other cancer diagnosis within the last 5 years (except for skin basalioma).
- Acute urinary tract infection requiring antibiotic treatment.
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- Prior radiotherapy or systemic chemotherapy.
- WHO performance status of 3 or 4.
- Any other investigational agent or non-marketed product within one month prior to Visit 1 and during the trial.
- Known active HIV infection, defined as detectable HIV viral load at screening.
- Active hepatitis B virus (HBV) infection, defined as hepatitis B surface antigen (HBsAg) positivity with detectable HBV DNA at screening.
- Active hepatitis C virus (HCV) infection, defined as anti-HCV antibody positivity with detectable HCV RNA at screening in a patient not on stable antiviral treatment.
- Any concurrent illness that may render a participant ineligible or limit compliance with study requirements.
- Previously enrolled in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Fakultni nemocnice Motol a Homolka
Prague, 15000
About this study
Official title: A Randomized Phase III Study to Investigate the Efficacy and Safety of Alpha1H as a Neoadjuvant Therapy in Participants With Low- to Intermediate-Risk/Low-Grade Papillary Non-Muscle Invasive Bladder Cancer
The goal of this clinical trial is to learn if the drug Alpha1H works to treat low-to-intermediate risk non-muscle-invasive bladder cancer in adults. It will also learn about the safety of drug Alpha1H.
The main questions it aims to answer are:
Read more
- Does giving drug Alpha1H before surgery lower the risk of cancer returning or worsening compared to standard care alone?
- Is drug Alpha1H safe and well-tolerated by participants? Researchers will compare participants receiving drug Alpha1H before standard surgery to participants receiving standard care alone to see if drug Alpha1H lowers the risk of cancer returning or progressing.
Participants will:
- Be randomly assigned to receive either drug Alpha1H before surgery or standard care alone.
- Receive drug Alpha1H directly into the bladder 6 times over about 1 month if assigned to the Alpha1H group.
- Hold the liquid in the bladder for up to 2 hours during each visit.
- Undergo standard surgery through the urethra (TURBT) to remove remaining tumor tissue.
- Visit the clinic regularly for follow-up checkups (including bladder examinations and urine tests) to check if the cancer returns.
- Fill out questionnaires about their quality of life.
- Being tested
- Alpha1H, Transurethral Resection of Bladder Tumor (TURBT), Intravesical Chemotherapy
- Keywords
- Non-Muscle Invasive Bladder Cancer, Papillary Bladder Carcinoma, Low-Grade Bladder Cancer, Low-Risk Bladder Cancer, Intermediate-Risk Bladder Cancer, Alpha1H, Neoadjuvant Therapy, Intravesical Instillation
- Medical subject headings
- Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha1HDrug
Administered via intravesical instillation directly into the urinary bladder. Participants in the experimental group receive a total of 6 instillations on Days 1, 3, 5, 8, 15, and 22 over approximately 1 month prior to TURBT. During each treatment, participants are asked to retain the solution in the bladder for up to 2 hours.
Transurethral Resection of Bladder Tumor (TURBT)Procedure or surgery
Standard endoscopic surgical procedure performed through the urethra to resect and remove papillary bladder tumor tissue. Performed approximately 30 days after study entry (on Visit 8). Resected tumor tissue is collected for histopathology and central analysis.
Intravesical ChemotherapyDrug
A single early intravesical instillation of standard-of-care chemotherapy (epirubicin, mitomycin, or gemcitabine) administered into the urinary bladder shortly following TURBT surgery in accordance with local institutional guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Alpha1H | Experimental | Participants receive 6 intravesical instillations of Alpha1H over approximately 1 month prior to transurethral resection of bladder tumor (TURBT). Receives: Drug: Alpha1H; Procedure: Transurethral Resection of Bladder Tumor (TURBT); Drug: Intravesical Chemotherapy |
| Standard of Care | Active comparator | Participants receive standard of care consisting of transurethral resection of bladder tumor (TURBT) followed by a single early intravesical instillation of standard chemotherapy. Receives: Procedure: Transurethral Resection of Bladder Tumor (TURBT); Drug: Intravesical Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-Free Survival (EFS)
Measured: From randomization until the occurrence of an EFS event or study completion, assessed at 3, 6, 9 (optional), and 12 months post-randomization, and every 6 months thereafter for up to 3 years.
Secondary outcomes (7)
Complete Response (CR) Rate
Measured: Day 30 (±5 days), prior to TURBT
Overall Survival (OS)
Measured: From randomization through study completion (assessed at 3, 6, 9 [optional], and 12 months, and every 6 months thereafter for up to 3 years).
Tumor Response (Morphological and Cellular)
Assessed as: (1) change in papillary tumor size (% reduction from baseline); (2) tumor cell shedding in urine (cells/mL); (3) apoptosis in shed cells (% TUNEL-positive cells); (4) Alpha1H uptake in shed cells (% Alpha1H-positive cells). Each parameter reported separately.
Measured: Baseline (Day 1) to Day 30 (±5 days)
Tumor Gene Expression
Assessed by RNA sequencing (whole transcriptome) in tumor tissue and urine RNA. Reported as number of differentially expressed cancer-related genes and pathways between the Alpha1H and SOC arms.
Measured: Baseline (Day 1) to Day 30 (±5 days)
Urinary Biomarkers and Immune Response
Assessed by proteomic profiling of urine samples. Reported as change in concentration (pg/mL) of cytokines, chemokines, and interferons between pre- and post-instillation samples, compared between the Alpha1H and SOC arms.
Measured: Day 1, 3, 5, 8, 15, and 22 (pre- and post-instillation), and Day 30 (±5 days)
Incidence and Severity of Adverse Events (AEs)
Measured: From Visit 1 (Screening) through Visit 9 (Day 40/50) and follow-up period (up to 3 years)
Change in Quality of Life (QoL) as Assessed by the QLQ-NMIBC24 Questionnaire
Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Non-Muscle-Invasive Bladder Cancer Module (EORTC QLQ-NMIBC24), a 24-item, disease-specific patient-reported outcome instrument. Each domain score is linearly transformed to range from 0 to 100. On functional scales (e.g., sexual function), higher scores indicate better functioning; on symptom-related scales (e.g., urinary symptoms, future perspective), higher scores indicate greater symptom burden. Scores are calculated per the EORTC scoring manual.
Measured: From Visit 1 (Screening) through follow-up visits (up to 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start17 Sep 2026
- Primary completionJul 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamlet Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804056
- Sponsor's protocol ID
- HP003-001
- Other IDs
- 2026-525531-16-00
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Study to Investigate the Efficacy and Safety of Alpha1H as a Neoadjuvant Therapy in Participants With Low- to Intermediate-Risk/Low-Grade Papillary Non-Muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT07804056
- Acronym / sponsor ID
- HP003-001
- Keywords
- Non-Muscle Invasive Bladder Cancer, Papillary Bladder Carcinoma, Low-Grade Bladder Cancer, Low-Risk Bladder Cancer, Intermediate-Risk Bladder Cancer, Alpha1H, Neoadjuvant Therapy, Intravesical Instillation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Hamlet Pharma ABIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2026 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if the drug Alpha1H works to treat low-to-intermediate risk non-muscle-invasive bladder cancer in adults. It will also learn about the safety of drug Alpha1H.
The main questions it aims to answer are:
- Does giving drug Alpha1H before surgery lower the risk of cancer returning or worsening compared to standard care alone?
- Is drug Alpha1H safe and well-tolerated by participants? Researchers will compare participants receiving drug Alpha1H before standard surgery to participants receiving standard care alone to see if drug Alpha1H lowers the risk of cancer returning or progressing.
Participants will:
- Be randomly assigned to receive either drug Alpha1H before surgery or standard care alone.
- Receive drug Alpha1H directly into the bladder 6 times over about 1 month if assigned to the Alpha1H group.
- Hold the liquid in the bladder for up to 2 hours during each visit.
- Undergo standard surgery through the urethra (TURBT) to remove remaining tumor tissue.
- Visit the clinic regularly for follow-up checkups (including bladder examinations and urine tests) to check if the cancer returns.
- Fill out questionnaires about their quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alpha1H | Experimental | Drug: Alpha1H, Procedure: Transurethral Resection of Bladder Tumor (TURBT), Drug: Intravesical ChemotherapyParticipants receive 6 intravesical instillations of Alpha1H over approximately 1 month prior to transurethral resection of bladder tumor (TURBT). |
| Standard of Care | Active comparator | Procedure: Transurethral Resection of Bladder Tumor (TURBT), Drug: Intravesical ChemotherapyParticipants receive standard of care consisting of transurethral resection of bladder tumor (TURBT) followed by a single early intravesical instillation of standard chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed and dated informed consent.
- Low- or intermediate-risk non-muscle-invasive bladder cancer (NMIBC) meeting one of the following definitions:
- Low-risk NMIBC: Primary, solitary, Ta, low-grade, 0.5 cm to 3 cm.
- Intermediate-risk NMIBC (low-to-intermediate risk subgroup per IBCG classification):
- Primary multifocal (<10 lesions), Ta, low-grade, 0.5 cm to 3 cm;
Key exclusion criteria (14 listed)
- Patient with non-papillary tumor appearance at the time of initial cystoscopy.
- Previous history of T1 or high-grade disease in recurrent tumors.
- Patients with T1 or high-grade non-muscle invasive papillary bladder cancer (NMIBC).
- Previous intravesical BCG immunotherapy.
- Patients with any other cancer diagnosis within the last 5 years (except for skin basalioma).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha1HAdministered via intravesical instillation directly into the urinary bladder. Participants in the experimental group receive a total of 6 instillations on Days 1, 3, 5, 8, 15, and 22 over approximately 1 month prior to TURBT. During each treatment, participants are asked to retain the solution in the bladder for up to 2 hours. | Drug | Alpha1H |
| Transurethral Resection of Bladder Tumor (TURBT)Standard endoscopic surgical procedure performed through the urethra to resect and remove papillary bladder tumor tissue. Performed approximately 30 days after study entry (on Visit 8). Resected tumor tissue is collected for histopathology and central analysis. | Procedure or surgery | Alpha1H, Standard of Care |
| Intravesical ChemotherapyA single early intravesical instillation of standard-of-care chemotherapy (epirubicin, mitomycin, or gemcitabine) administered into the urinary bladder shortly following TURBT surgery in accordance with local institutional guidelines. | Drug | Alpha1H, Standard of Care |
Primary outcome
Event-Free Survival (EFS)
Time frame: From randomization until the occurrence of an EFS event or study completion, assessed at 3, 6, 9 (optional), and 12 months post-randomization, and every 6 months thereafter for up to 3 years.
7 secondary outcomes
Complete Response (CR) Rate
Time frame: Day 30 (±5 days), prior to TURBT
Overall Survival (OS)
Time frame: From randomization through study completion (assessed at 3, 6, 9 [optional], and 12 months, and every 6 months thereafter for up to 3 years).
Tumor Response (Morphological and Cellular)
Time frame: Baseline (Day 1) to Day 30 (±5 days)
Tumor Gene Expression
Time frame: Baseline (Day 1) to Day 30 (±5 days)
Urinary Biomarkers and Immune Response
Time frame: Day 1, 3, 5, 8, 15, and 22 (pre- and post-instillation), and Day 30 (±5 days)
Incidence and Severity of Adverse Events (AEs)
Time frame: From Visit 1 (Screening) through Visit 9 (Day 40/50) and follow-up period (up to 3 years)
Change in Quality of Life (QoL) as Assessed by the QLQ-NMIBC24 Questionnaire
Time frame: From Visit 1 (Screening) through follow-up visits (up to 3 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alpha1H, Transurethral Resection of Bladder Tumor (TURBT) and Intravesical Chemotherapy in people with Urinary Bladder Neoplasms and Non-muscle Invasive Bladder Cancer (NMIBC), run by Hamlet Pharma AB at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catharina Svanborg, MD, PhD. (+46709426549, catharina.svanborg@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-Free Survival (EFS) (time frame: From randomization until the occurrence of an EFS event or study completion, assessed at 3, 6, 9 (optional), and 12 months post-randomization, and every 6 months thereafter for up to 3 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.